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Trends in Biopharmaceutical Characterisation

I’m writing this article following a day at NIBRT (National Institute for Bioprocessing Research and Training) in Dublin, Ireland attending the Thermo Fisher Scientific Biopharma Summit. NIBRT and Thermo Fisher Scientific are collaborating to develop new applications and methods for the characterisation of biotherapeutics to address the evolving trends and demands of the biopharmaceutical industry, such as:

Speed, flexibility, quality and cost control: getting it right the first time

Patent cliff fuelling growth of biosimilars

Workflow based solutions and a general deskilling of the workforce

The presentations delivered during the summit looked at the main biomolecule characterisation workflows in biopharma and how new technologies and methods are addressing the requirements above. Below is a brief summary of some of the main points from the summit and I’ve also included a relevant application note developed by NIBRT and Thermo Fisher Scientific on the topic where appropriate.

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Multi-Attribute Method (MAM) – There are numerous characteristics that need to be analysed on a biotherapeutic and no single technique that can analyse them all, hence the requirement to use different techniques and technologies to gain a complete understanding. This is obviously time consuming and requires expertise in a number of techniques which is not conducive to continuous production and single-use technology. The multi-attribute method uses peptide mapping and high-resolution accurate mass spectrometry (HRAM) to analyse multiple attributes in parallel and at high speed. Suggested application note: Robust and reproducible peptide mapping and intact mass analysis workflows on a single instrument platform

Hydrophobic Interaction Chromatography (HIC) – Prof. Sebastiaan Eeltink, research professor at the Department of Chemical Engineering at the Free University of Brussels described his research in to hydrophobic interaction chromatography. HIC is still relatively poorly understood, but it was shown that by adjusting the concentration and switching buffer salts as well as using different HIC columns it is possible to achieve previously unseen separation of proteins such as monoclonal antibodies and antibody-drug conjugate

Charge Variant Analysis – An alternative approach to the traditional ion exchange chromatography and salt gradient method was proposed by both Alexander Schwahn of Thermo Fisher Scientific and Jonathan Bones, Principal Investigator of NIBRT. The new approach uses a linear pH gradient produced by the Thermo Scientific™ CX1 buffers allowing for minimal method development and fast and reproducible separations. Jonathan Bones also presented modified pH gradient buffers that allow for direct mass spectrometry analysis of the native, intact, monoclonal antibody charge variants. Suggested reading : Using the NISTmAb reference standard to demonstrate a simple approach to charge variant analysis

Glycan Analysis – Throughout the day numerous different strategies were provided for the analysis of glycan composition, attachment sites and quantification at both the peptide and intact protein level. A fast glycan screening approach was described that utilises capillary electrophoresis to provide high resolution separation, comparable to UHPLC, and analysis of 96 samples in just five hours. Learn more: Glycan Analysis of Biotherapeutics

Host Cell Proteins – There are multiple different options available to monitor host cell proteins, such as ELISA and western blotting. Today we heard about a simple LC-MS approach that utilises methodology common to proteomics, namely 1D nano-LC with long columns. It was also shown that this approach is easily transferred to analytical scale UHPLC which is common in most laboratories.

The main take-away from my day at the summit is that the biopharmaceutical characterisation landscape is evolving quickly, but technologies and applications are being developed to overcome the challenges that are being presented. The collaboration between Thermo Fisher Scientific and NIBRT is at the forefront of this application development with these new developments frequently shared in the form of application notes, short application videos and the placing of these methods on the Thermo Scientific AppsLab Library of Analytical Applications – the links take you to an example of each. NIBRT and Thermo Fisher Scientific are frequently posting new applications. Make sure you keep up to date with the latest applications in biopharmaceutical characterisation.

Additional Resources

Keep up to date with the latest developments on biopharmaceutical analytical testing with the learning centre.

Details on the upcoming biopharma summits as well the presentations when they become available can be found here.

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